Nobel Perfect Implant System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K030257 ↗

FDA Product Code

DZE

Device Class

Class II

Regulation

21 CFR Part 872.3640

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Replace One Piece Implant, Ha, Replace One Piece Implant, Tiunite

  Class II

  FDA 510(k) K023952 Active Cleared 16 Jan 2003

• Procera Preparable Abutment System

  Class II

  FDA 510(k) K974150 Active Cleared 23 Jan 1998

• Replace Ha Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162, 50102, 50132, 50162, 60102, 60132, & 60162

  Class II

  FDA 510(k) K020646 Active Cleared 29 May 2002

• Inplant Orthodontic Anchor System

  Class II

  FDA 510(k) K000643 Active Cleared 7 Sep 2000

• Branemark System(R) Ebon(Tm) Fixture

  Class II

  FDA 510(k) K974828 Active Cleared 24 Mar 1998

• Branemark System Zygomaticus Fixture System

  Class II

  FDA 510(k) K970499 Active Cleared 16 Oct 1997

See all devices from Nobel Biocare Uas, Inc. →

• What is the Nobel Perfect Implant System used for?

  The Nobel Perfect Implant System is designed for dental procedures and consists of implant components intended for the replacement of missing teeth. It provides a solution for patients who have lost teeth due to various dental conditions.

• How is the Nobel Perfect Implant System supplied?

  The system is supplied as a sterile, single-use device, ensuring infection control and safety for each patient. It is available in various sizes to accommodate different clinical needs and anatomical considerations.

• Is the Nobel Perfect Implant System MRI safe?

  Yes, the Nobel Perfect Implant System is MRI safe, meaning it can be safely used with MRI imaging without causing significant image artifacts or patient discomfort during diagnostic procedures.

• What regulatory approval does the Nobel Perfect Implant System have?

  The Nobel Perfect Implant System has received FDA 510K clearance as substantially equivalent under product code DZE. This clearance indicates that the device is substantially equivalent to legally marketed devices in the United States.